Kornimate/medical-research-clean huggingface dataset:
speed manipulated adaptive rehabilitation therapy bike for parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. these symptoms significantly affect pd patients' quality of life, independence, and functional performance. there is currently no cure for pd, but symptoms can be treated with levodopa or deep brain stimulation surgery. exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. cycling-based interventions have been shown to increases motor function and mobility in individuals with pd. specifically, benefits are greater when cycling cadence (revolutions per minute, rpm) is 30% greater than a self-selected pace. although high cadence cycling improves motor function in individuals with pd, there is significant heterogeneity in individual responses. to maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. the entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. the purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with pd. volunteers with parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.

potential participants will be prescreened with the acsm pre-participation questionnaire over the phone or in person. those who qualify will be asked to visit the research lab and sign the informed consent. participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. for the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. the optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. after optimization, participants will receive specific settings for the next session. for the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * 50-79 years of age * no contraindications to exercise including cardiovascular disease or stroke exclusion criteria: * one or more major signs/symptoms of cardiovascular or pulmonary disease

Keywords: movement disorders exercise adaptive therapy cycling
axillary drainage following lymph node dissection in women with stage i or stage ii breast cancer

Conditions: Breast Cancer; Lymphedema; Perioperative/Postoperative Complications

Summary: rationale: the use of axillary drains may help to prevent complications following axillary lymph node dissection. purpose: this randomized clinical trial is comparing three methods of axillary drainage to see how well they work following lymph node dissection in women with stage i or stage ii breast cancer.

objectives: * compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage i or ii breast cancer. outline: this is a randomized study. patients undergo axillary dissection, then are randomized to one of three axillary drainage systems. * arm i: patients receive high vacuum drainage. * arm ii: patients receive low vacuum drainage. * arm iii: patients receive simple tube drainage (no vacuum). all drains are removed when daily volumes are below 30 ml or at 5 days after surgery, regardless of drain volume. patients are followed at day 10 and at 3 months. projected accrual: a total of 200 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of resectable stage i or ii breast cancer * planned primary surgery of level ii or iii axillary dissection in association with one of the following: * wide local excision (may be done through separate incision) * no breast surgery * bilateral surgery allowed * no prior mastectomy * no immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * no prior radiotherapy surgery: * see disease characteristics * no prior axillary surgery

Keywords: stage i breast cancer stage ii breast cancer lymphedema perioperative/postoperative complications
bvait: b-vitamin atherosclerosis intervention trial

Conditions: Atherosclerosis

Summary: the purpose of this study is to examine whether vitamin b supplementation will reduce the progression of early atherosclerosis in individuals over 40 years old and without clinical evidence of cardiovascular disease (cvd).

the primary hypothesis to be tested is that daily vitamin b supplementation reduces progression of early atherosclerosis. ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and ct will be used to measure coronary and aortic calcium. the beneficial effects of vitamin b supplementation are expected to occur with or without a change in ldl-c levels. a total of 506 men and women will be randomized to receive either 1) vitamin b supplementation consisting of folic acid 5mg, vitamin b12 0.4mg, and vitamin b6 50mg, or 2) a matching placebo. participants will receive ultrasonography at baseline and every 6 months for 2.5 to 4.5 years, and ct scan at baseline and end of study (2.5 to 4.5 years).

Eligibility criteria:
inclusion criteria: * male or female (postmenopausal) * 40 years or older * fasting plasma homocysteine 8.5 micromoles per liter (µmol/l) or greater exclusion criteria: * any clinical signs or symptoms of cardiovascular disease (cvd) * diabetes mellitus or fasting serum glucose 140 mg/dl or greater * triglyceride (tg) levels 500mg/dl or greater * serum creatinine greater than 1.6 mg/dl * uncontrolled hypertension (systolic blood pressure 160 mmhg or greater and/or diastolic blood pressure 100 mmhg or greater) * thyroid disease (untreated) * life threatening disease with prognosis less than 5 years * alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug use, cocaine use)

Keywords: cardiovascular disease cvd
a study to validate and improve an automated image analysis algorithm to detect tuberculosis in sputum smear slides

Conditions: Tuberculosis, Pulmonary

Summary: a study to validate and improve an automated image analysis algorithm to detect tuberculosis in sputum smear slides


Eligibility criteria:
inclusion criteria: * samples sourced from makerere university's joint clinical research clinic (jcrc) and laboratory exclusion criteria: * no samples from outside makerere's domain
manifestations of ocular irritation following pterygium excision with sutures fixed conjunctival autograft

Conditions: Pterygium

Summary: in this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. the severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. the localized nasal quadrant conjunctival hyperemia was also evaluated. it was found that sutures fixed conjunctival auto-graft can be used safely with short-term minimal to moderate tolerable manifestations of ocular irritation with no significant complications.

all the patients were subjected to pterygium excision surgery with conjunctival auto-graft under local anesthesia. the graft was fixed by vicryl 8-0 sutures.ocular irritation symptoms including pain, foreign body sensation and watering were subjectively evaluated. pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep. foreign body sensation and watering of the eye were evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome. the score of patients' subjective symptoms evaluation were collected in a total score which ranged from zero to a maximum of 10. a total score of 3 or less was considered as minimal irritation (grade i), 4-6 was considered as mild-moderate tolerable irritation (grade ii), and 7 or more was considered as severe annoying irritation (grade iii). the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 2 weeks, 1,2 and 3 months post-operative using the cornea and contact lens research unit (cclru) photographic grading scale. in this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe. decimal fraction of 0.5 was added to describe the intermediate cases.

Eligibility criteria:
inclusion criteria: * patients with pterygium exclusion criteria: * previous ocular surgeries * ocular surface disorders

Keywords: pterygium excision conjunctival auto-graft ocular irritation conjunctival hyperemia
safety and performance of a vascular patch in pediatric patients undergoing bidirectional cava-pulmonary anastomosis

Conditions: Heart Defects, Congenital

Summary: xeltis developed biodegradable patch prosthesis, the vascular patch model cor-vp-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. the prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. the xeltis vascular graft model cor-vp-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.

xeltis has developed a medical device for treating pediatric cardiovascular patients requiring rvot reconstruction. xeltis' mission is to offer 'solutions for a lifetime' to cardiovascular patients. xeltis has developed a unique technology based on novel biodegradable bio-materials allowing the regrowth of natural heart valves or blood vessels in patients' bodies from their own cells. the principle of xeltis' cor technology (cor stands for cardiovascular organ regeneration) is to implant a biodegradable prosthesis of a blood vessels that is shaped like the part to be replaced. the prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. tissue is regenerated and functional by the time the polymer is biodegraded.

Eligibility criteria:
inclusion criteria: 1. patient requiring a bidirectional cava-pulmonary anastomosis 2. male or female 3. age: 2 months to 16 years exclusion criteria: 1. main exclusion criteria arrhythmias as determined by ecg and/or at the investigator's discretion 2. other clinically significant malformations 3. coagulation disorders as defined by inr outside its normal value, ptt \>uln and fibrinogen \<lln and/or at the investigator's discretion 4. hiv-infection 5. syphilis (treponema pallidum) 6. hepatitis-b and/or -c virus infection 7. unwillingness of parental/legal guardian to give consent 8. treatment with other investigational products 9. known or suspected noncompliance, drug or alcohol abuse of the parents/legal guardian 10. inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems 11. participation of the patient in another study within 30 days preceding and during the present study 12. previous enrolment of the patient into the current study 13. enrolment of the investigator's family members, employees and other dependent persons
fabry: renal function during long-term ert by 51cr-edta clearance

Conditions: Fabry Disease

Summary: the aim of this study was to investigate renal function decline by measured glomerular filtration rate (mgfr) in patients with fd during enzyme replacement therapy, and to explore the influence of age on renal function in fd.

nephropathy is common in fabry disease (fd). renal function decline is often the first sign of major organ involvement, sometimes progressing to end-stage renal failure. available studies of renal function during enzyme replacement therapy have shown inconsistent results, and are based on different composition of patient materials and follow-up time. most investigations have used estimated glomerular filtration rate (egfr) for evaluating renal function. gfr is an important indicator of renal function. egfr based on a serum creatinine measurement is most commonly used in fd. however, this method has been shown to be unreliable, as serum creatinine levels are influenced by other factors than renal function such as ethnic group, muscle mass, age, hydration and diet. performance of egfr in detecting minor changes in renal function is poor. a 10 year old review on renal function evaluation in patients with fd recommended the use of gfr based on an exogenous marker, e.g. cr-edta. nevertheless, only few studies have used mgfr for evaluation of renal function and to our knowledge, the present study is the first to describe the rate of renal function decline with consecutive mgfr values in a nationwide population of patients with fd. renal function declines with age in renal healthy individuals. to our knowledge, the present study is the first to age-standardize renal function in patients with fd to adjust for age-dependent renal deterioration.

Eligibility criteria:
inclusion criteria: * genetically and/or enzymatically verified fabry disease exclusion criteria: * end-stage renal disease prior to baseline (gfr \<15 ml/min/1.73m2, dialysis or renal transplant) * patient has not received enzyme replacement therapy during follow-up * patient has had less than 3 measurement of gfr during follow-up

Keywords: fabry disease nephropathy measured gfr enzyme replacement therapy
phase i th-302 plus gemcitabine plus nab-paclitaxel in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a multicenter, open-label, phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended phase 2 dose (rp2d) of th-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: * subjects greater than or equal to (\>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than: * radiosensitizing doses of 5-fluorouracil; * radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine; * neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection; * adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy * subjects may have measurable or non-measurable disease according to recist 1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1 * acceptable hematological status, liver and renal function as defined in the protocol * other protocol defined inclusion criteria could apply exclusion criteria: * significant cardiac or peripheral vascular arterial disease * known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months) * severe chronic obstructive or other pulmonary disease with hypoxemia * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * subjects receiving concomitant treatment with radiotherapy or other investigational drugs * other protocol defined exclusion criteria could apply

Keywords: th-302 nab-paclitaxel gemcitabine evofosfamide
effects of continuous haemofiltration vs intermittent haemodialysis on microcirculatory parameters in septic shock

Conditions: Septic Shock

Summary: the aim of the study was to investigate whether cvvh, in comparison to intermittent haemodialysis (ihd), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis

a prospective, randomized, clinical study ,including septic shock patients with acute renal failure, aged over 16 years. patients were randomized to receive either cvvh or ihd for renal replacement therapy. intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

Eligibility criteria:
inclusion criteria: * septic shock exclusion criteria: -

Keywords: continuous haemofiltration intermittent haemodialysis
determinants of formate concentrations

Conditions: Healthy

Summary: formate is an important metabolite, serving as a donor of one-carbon groups to the intracellular tetrahydrofolate pool. however, little is known of its circulating concentrations or of their determinants. this study seeks to define formate levels and their determinants in a young, healthy population. serum formate will be measured in 1701 subjects from the trinity student study. the subjects, males and females, aged 18 to 28 years, were enrolled at trinity college, dublin. formate levels will be compared with other one-carbon metabolites, vitamin status, potential formate precursors, genetic polymorphisms, and lifestyle factors.


Eligibility criteria:
inclusion criteria: * trinity college dublin students with irish grandparents exclusion criteria: * none

Keywords: formate one-carbon metabolism
comparison of proton and carbon ion radiotherapy with advanced photon radiotherapy in skull base meningiomas: the pinocchio trial.

Conditions: Skull Base Meningioma

Summary: in pinocchio-triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. there will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. the study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. the study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.


Eligibility criteria:
inclusion criteria patients meeting all of the following criteria will be considered for admission to the trial: * histologically or imaging confirmed skull base meningioma * macroscopic tumor - simpson grade 4 or 5 * age ≥ 18 years of age * karnofsky performance score \>=60 * for women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.) * female participants: no pregnancy present (pregnancy test required) * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) exclusion criteria: patients presenting with any of the following criteria will not be included in the trial: * refusal of the patients to take part in the study * previous radiotherapy of the brain * histologically confirmed atypical or anaplastic meningioma * optic nerve sheath meningioma (onsm) * patients who have not yet recovered from acute toxicities of prior therapies * known carcinoma \< 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * pregnant or lactating women * participation in another clinical study or observation period of competing trials, respectively.
heart matters: the effectiveness of heart health education in regions at highest-risk.

Conditions: Acute Coronary Syndrome; Myocardial Infarction, Acute

Summary: the aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve acs patient's symptom recognition and response. the intervention will be will be evaluated according to a cluster randomized, stepped wedged design. the clusters are eight local government areas (lgas) in victoria, australia. the main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six lgas throughout the study period with an ed diagnoses of acute coronary syndrome.

primary objectives: to determine if targeted heart health education will: 1. increase ambulance use in acs patients (main primary outcome); 2. decrease patient and prehospital delay times in acs patients; 3. increase awareness of personal cardiovascular risk and associated factors in adult community members; and 4. increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members. secondary objectives 1. to determine if targeted heart health education: 2. reduces the incidence of out-of-hospital cardiac arrest; 3. improves survival in ohca patients; 4. improves survival in acs patients; 5. improves survival and acs patients; 6. increases presentations to ed for acs and unspecified chest pain; and 7. increases the rates of calls to ambulance for chest pain and non-chest pain. 8. increases the rate of heart health checks. intervention: to meet the objectives of the study, we will employ hm coordinators for each of the eight high-risk lgas to organise and deliver our hm education program using hm materials and partner resources. design: the stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period. over the 16-month study period, the eight lgas will move into the intervention phase at two month intervals. as four lgas are in close proximity, these lgas will switch from control to intervention periods at the same time to avoid possible contamination.

Eligibility criteria:
inclusion criteria: adult residents of the eight local government areas - exclusion criteria: adults not residing in the eight local government areas. -